I-Hubei JXBio Pharmaceutical Co., Ltd., indawo yokukhiqiza i-peptide ezinikele ye-JYMed, iqedele ngempumelelo okunye ukuhlola endaweni okwenziwa yi-US Food and Drug Administration (FDA) kusukela ngoMashi 10-14. Ukuhlolwa, okuyingxenye yokuhlolwa kwe-Drug Quality Assurance, kuhlaziye izinhlelo ezibalulekile ezihlanganisa ikhwalithi, ukukhiqizwa, okokusebenza kanye nezinsiza, izilawuli zelabhu, nokuphathwa kwezinto ezibonakalayo. Ama-API abuyekeziwe afaka i-Liraglutide, i-Semaglutide, i-Tirzepatide, ne-Oxytocin.

Ngemva kokuhlolwa, i-FDA ikhiphe umbiko osemthethweni wokuhlola i-Establishment Inspection Report (EIR), eqinisekisa ukuthi imisebenzi ka-Hubei JXBio ihlangabezana namazinga aphezulu e-ejensi ngekhwalithi nokuhambisana.

Lokhu kuphawula ukuhlolwa kwesibili okulandelanayo kwe-FDA okuphasiswe yisikhungo sethu sase-Hubei, kuqinisekisa kabusha ukuzibophezela kwethu ezinhlelweni zokukhiqiza nezisezingeni eliphezulu. Iphinde ivule indlela yokubhaliswa komkhiqizo okushelelayo emhlabeni wonke futhi iqinise isikhundla sethu emakethe ye-peptide yamazwe ngamazwe.

Mayelana ne-JYMed

I-JYMed yinkampani yemithi yobuchwepheshe obuphezulu egxile ocwaningweni, ekuthuthukisweni, ekukhiqizeni nasekudayiseni imikhiqizo esekwe ku-peptide. Siphinde futhi sinikeze ngezinsizakalo ze-CDMO zokuphela-to-ekupheleni, ezinikeza izixazululo ze-peptide ezenzelwe wena kumaklayenti emithi, ezozimonyo, nawezilwane emhlabeni jikelele.

Iphothifoliyo yethu yomkhiqizo ihlanganisa inqwaba yama-API we-peptide. Imikhiqizo ye-Flagship efana ne-Semaglutide ne-Terlipressin igcwalise ngempumelelo ukufakwa kwe-US FDA DMF.

Inkampani yethu ephethwe ngokugcwele, i-Hubei JXBio, isebenzisa imigqa yokukhiqiza ye-peptide API esezingeni eliphezulu eklanyelwe ukuhlangabezana namazinga e-cGMP asethwe yi-US FDA kanye ne-NMPA yaseChina. Lesi sikhungo sihlanganisa imigqa yokukhiqiza eyi-10 emikhulu kanye neyokuhlola, esekelwa uhlelo oluqinile lokulawulwa kwekhwalithi yezemithi (QMS) kanye nohlelo oluqinile lwezempilo nokuphepha kwemvelo (EHS).

I-JXBio iphumelele ukuhlolwa kwe-GMP yi-FDA yase-US kanye ne-NMPA yase-China futhi iqashelwa izinkampani ezihola phambili zemithi emhlabeni wonke ngokuvelela ekuphathweni kwe-EHS, okubonisa ukuzibophezela kwethu okungantengantengi kukhwalithi, ukuphepha, nokunakekela imvelo.

Izindawo Zebhizinisi Eziyinhloko

• Ukubhaliswa komhlaba wonke kanye nokuhambisana nokulawula kwama-API e-peptide

• Imikhiqizo ye-peptide yezilwane kanye nezimonyo

• Ukuthuthukiswa nokukhiqizwa kwe-peptide ngokwezifiso (CRO, CMO, OEM)

• Ama-Peptide-drug conjugates (PDCs), okuhlanganisa:

• Ama-conjugates e-Peptide–radionuclide

• I-Peptide–ama-conjugate e-molecule encane

• I-Peptide–protein conjugates

• Imithi yokwelapha ye-Peptide-RNA

IMIKHIQIZO EYINHLOKO

Ukuze uthole ulwazi olwengeziwe mayelana nemikhiqizo yethu, sicela usithinte:

I-Global API kanye nemibuzo yezimonyo: +86-150-1352-9272

Ukubhaliswa kwe-API Nezinsizakalo ze-CDMO (izimakethe zase-US ne-EU): +86-158-1868-2250

I-imeyili:jymed@jymedtech.com

Ikheli: Floors 8 & 9, Building 1, Shenzhen Biomedical Innovation Industrial Park,

14 Jinhui Road, Kengzi Subdistrict, Pingshan District, Shenzhen, China